Algernon Pharmaceuticals Files U.S. FDA Pre-IND Meeting Request for Ifenprodil Small Cell Lung Cancer Study
Algernon Pharmaceuticals has filed a pre-IND meeting request with the U.S. FDA for its clinical program investigating NP-120 (Ifenprodil) for the treatment of small cell lung cancer (SCLC). This marks a significant step in the development of Ifenprodil, which shows promise when combined with Topotecan to inhibit tumor growth. SCLC accounts for 15% of lung cancers, with limited treatment options available for patients suffering from this condition. CEO Christopher J. Moreau expressed optimism about advancing the SCLC program rapidly, emphasizing the urgent need for new treatment avenues.
- Filed pre-IND meeting request with the U.S. FDA for NP-120 treatment in SCLC.
- Investigating Ifenprodil, showing promising results in combination with Topotecan.
- SCLC presents an urgent medical need, potentially increasing market opportunity.
- None.
VANCOUVER, British Columbia, Sept. 22, 2021 (GLOBE NEWSWIRE) -- Algernon Pharmaceuticals Inc. (CSE: AGN) (FRANKFURT: AGW) (OTCQB: AGNPF) (the “Company” or “Algernon”) a clinical stage pharmaceutical development company is pleased to announce that it has filed a pre-IND (Investigational New Drug) meeting request with the U.S. Food and Drug Administration (U.S. FDA) for its investigation of NP-120 (Ifenprodil) for the treatment of small cell lung cancer (SCLC).
This initiates formal communications with the U.S. FDA regarding development of the Company’s newly announced SCLC clinical research program and related license agreement with Dartmouth College.
In the pre-IND meeting request application, the Company is confirming the direction it plans to take in the development of Ifenprodil as an adjunct to Topotecan for the treatment of chemo refractory SCLC.
SCLC represents 15 percent of all lung cancers and occurs almost exclusively in smokers. It is distinguished from non-small cell lung cancer by its rapid doubling time, high growth fraction, and the early development of widespread metastases. Although considered highly responsive to chemotherapy and radiotherapy, SCLC usually recurs within 14 to 15 months for patients with limited-stage SCLC and five to six months for patients with extensive-stage SCLC. Many of these patients are candidates for additional systemic treatment. The median survival of patients with relapsed SCLC ranges from two to six months. 1
The Company’s decision to investigate Ifenprodil and move it into human trials for SCLC is based on a study published in January 2019, entitled “Small-Cell Lung Cancer Growth Inhibition: Synergism Between NMDA Receptor Blockade and Chemotherapy”. In the study, Ifenprodil in combination with chemotherapeutic agent Topotecan, produced clear additive effects that completely blocked tumor growth.
Study Link: Small Cell Study
“I am very pleased that our team has been able to advance our SCLC program so quickly with this pre-IND filing,” said Christopher J. Moreau CEO of Algernon Pharmaceuticals Inc. “People who are suffering from chemo refractory SCLC have very few options and so we are hoping to be able to move Ifenprodil directly into a U.S. clinical trial as soon as possible.”
About Ifenprodil
Ifenprodil is an N-methyl-D-aspartate (NMDA) receptor antagonist specifically targeting the NMDA-type subunit 2B (GluN2B). Ifenprodil prevents glutamate signalling. The NMDA receptor is found on many tissues including lung cells, T-cells, and neutrophils and certain types of cancer cells.
About Algernon Pharmaceuticals Inc.
Algernon is a drug re-purposing company that investigates safe, already approved drugs, including naturally occurring compounds, for new disease applications, moving them efficiently and safely into new human trials, developing new formulations and seeking new regulatory approvals in global markets. Algernon specifically investigates compounds that have never been approved in the U.S. or Europe to avoid off label prescription writing.
1 https://www.uptodate.com/contents/treatment-of-refractory-and-relapsed-small-cell-lung-cancer#!
CONTACT INFORMATION
Christopher J. Moreau
CEO
Algernon Pharmaceuticals Inc.
604.398.4175 ext 701
info@algernonpharmaceuticals.com
investors@algernonpharmaceuticals.com
www.algernonpharmaceuticals.com.
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FAQ
What is the purpose of Algernon Pharmaceuticals' pre-IND filing for AGNPF?
What is the significance of NP-120 in the treatment of small cell lung cancer?
When did Algernon Pharmaceuticals file the pre-IND request for AGNPF?
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